Abstract
A sensitive and stereoselective HPLC method has been developed for the simultaneous determination of pindolol enantiomers in plasma and pharmaceutical products. Enantiomeric resolution was achieved on a cellulose tris(3,5-dimethylphenylcarbamate) immobilized onto a 5 μm spherical porous silica chiral stationary phase (CSP) known as Chiralpak IB with fluorescence detection set at 266 nm for excitation and 308 nm for emission. The mobile phase consists of n-hexane–isopropanol–triethylamine, (50:50:0.5), (v/v/v) has been used at a flow rate of 1.0 ml/min. The method was highly specific where other coformulated drugs such as clopamide and isosorbide did not interfere. The stability of pindolol enantiomers under different degrees of temperature was studied. The method validated for its linearity, accuracy, precision and robustness. There was no significant difference (p>0.05) between inter- and intra-day studies for each enantiomers which confirmed the reproducibility of the assay method. Preliminary data suggest that S-(−)-pindolol induces less bradycardia but more sedation and central nervous system depression than racemic pindolol.
Highlights
Chiral resolution of enantiomers by liquid chromatography is one of the emerging areas as one of the enantiomers may be inactive or toxic [1]
NMR and other spectroscopic techniques are supposed to have the capacity for ascertaining the chiral recognition mechanisms, which use high polar solvents (THF, acetone, pyridine, etc.) for this purpose and these solvents cannot be used in the coated chiral stationary phase (CSP) [5]
In this article we report the development and validation of pindolol analysis in rat plasma and pharmaceutical formulations using HPLC with fluorescence detection after enantiomeric resolution on Chiralpak IB column
Summary
Chiral resolution of enantiomers by liquid chromatography is one of the emerging areas as one of the enantiomers may be inactive or toxic [1]. It is interesting to note that all available polysaccharide chiral stationary phases are coated on silica support, which restricts the uses of some prohibited solvents such as tetrahydrofuran (THF), chlorofom, dichloromethane, ethylacetate, pyridine, acetone, and certain ethers as eluents [5, 6]. Due to these facts, coated CSPs are not capable to resolve certain drugs and pharmaceuticals, especially in the reaction mixtures having prohibited solvents. In this article we report the development and validation of pindolol analysis in rat plasma and pharmaceutical formulations using HPLC with fluorescence detection after enantiomeric resolution on Chiralpak IB column. With the present broad range of available CSPs and advances in column technology, the present enantioselective HPLC can be considered as the method of choice
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